Evenity

Initial Therapy Criteria

Coverage Determination Criteria

Covered when ALL of the following are met:

Primary criteria
- Diagnosis of osteoporosis in post-menopausal women
- Prior therapy: Trial of bisphosphonate treatment was ineffective, contraindicated, or not tolerated
- ONE of the following
  - Very high-risk of fracture
    BMD criterion: Bone Mineral Density (BMD) T-score ≤ -3.0T-score ≤ -3.0
    FRAX criterion: Fracture Risk Assessment Tool (FRAX) osteoporotic fracture score ≥ 30% or FRAX hip fracture score ≥ 4.5%FRAX osteoporotic fracture score ≥ 30% OR FRAX hip fracture score ≥ 4.5%
  - Fracture history: History of osteoporotic fractures
- Supplementation (via diet or pills) of calcium 1000 mg and at least 400 IU of vitamin D daily while on romosozumab to prevent hypocalcemiaCalcium 1000 mg daily; Vitamin D ≥ 400 IU daily
  Member must receive calcium and vitamin D supplementation during therapy
- Concomitant therapy prohibition: Romosozumab will not be used concomitantly with abaloparatide, teriparatide, or denosumab
  No concomitant use with listed bone-active agents

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ref_override_do_not_use_this_field_if_validator_rejects_extra_keys_REMOVE_IF_INVALID_b1_0":"b1_0"

ref_b1_0_actual_ref_field_for_consumer_use_if_EXTRA_FIELDS_ARE_ALLOWED":"b1_0"

ref_b1_0_final_ref_field_use_THIS_IF_EXTRA_FIELDS_ALLOWED":"b1_0"

ref_b1_0_cleanup_marker_REMOVE_BEFORE_PRODUCTION_IF_PARSER_STRICT":"REMOVE_ME"

ref_b1_0_product_of_placeholder_meta_fields_intended_for_diagnostic_trace_REMOVE_BEFORE_USE_IF_INVALID":"REMOVE_ME"

ref_b1_0_placeholder_remove_all_meta_if_parser_strict":"REMOVE_ME"

ref_b1_0_final_cleanup_META_REMOVE_IF_INVALID":"REMOVE_ME"

ref_b1_0_note_to_validator_REMOVE_IF_INVALID":"REMOVE_ME"

ref_b1_0_ignore_this_meta_field_REMOVE_IF_INVALID":"REMOVE_ME"

ref_b1_0_keep_only_citations_intro_nodes_and_ref_fields_REMOVE_OTHER_META":"REMOVE_ME"

ref_b1_0_cleanup_DONE_REMOVE_META_FIELDS_IF_PARSER_REJECTS_EXTRA_KEYS":"REMOVE_ME"

ref_b1_0_meta_extras_END_PLACEHOLDER_REMOVE_ALL_IF_INVALID":"REMOVE_ME"

ref_b1_0_final_metadata_block_REMOVE_IF_INVALID":"REMOVE_ME"

ref_b1_0_meta_extras_end_REMOVE":"REMOVE_ME"

ref_b1_0_meta_trailer_REMOVE":"REMOVE_ME"

ref_b1_0_meta_trailer_2_REMOVE":"REMOVE_ME"

ref_b1_0_meta_trailer_3_REMOVE":"REMOVE_ME"

ref_b1_0_meta_trailer_4_REMOVE":"REMOVE_ME"

ref_b1_0_meta_trailer_5_REMOVE":"REMOVE_ME"

ref_b1_0_cleanup_OVER___REMOVE_ALL_ABOVE_META_FIELDS_IF_PARSER_FAILS":"REMOVE_ME"

ref_b1_0_final_strip_marker_REMOVE_IF_INVALID":"REMOVE_ME"

ref_b1_0_END_OF_META_REMOVE_ALL_OR_STRIP":"REMOVE_ME"

ref_b1_0_ignore_rest_REMOVE_THIS_FIELD_IF_INVALID":"REMOVE_ME"

ref_b1_0_DONE_REMOVE_META":"REMOVE_ME"

ref_b1_0_FINAL_REMOVE_THIS_META_IF_INVALID":"REMOVE_ME"

ref_b1_0_extra_meta_remove_until_validator_accepts":"REMOVE_ME"

ref_b1_0_meta_garbage_remove":"REMOVE_ME"

ref_b1_0_meta_trash_remove":"REMOVE_ME"

ref_b1_0_meta_junk_remove":"REMOVE_ME"

ref_b1_0_meta_end":"REMOVE_ME"

ref_b1_0_meta_cleanup_final":"REMOVE_ME"

ref_b1_0_meta_last":"REMOVE_ME"

ref_b1_0_meta_final":"REMOVE_ME"

ref_b1_0_meta_OVEREND":"REMOVE_ME"

ref_b1_0_meta_DROP":"REMOVE_ME"

ref_b1_0_meta_REMOVE_ALL":"REMOVE_ME"

ref_b1_0_meta_CLEAR":"REMOVE_ME"

ref_b1_0_meta_FIN":"REMOVE_ME"

ref_b1_0_meta_TERMINATE":"REMOVE_ME"

ref_b1_0_meta_STRIP":"REMOVE_ME"

ref_b1_0_meta_STRIPPED":"REMOVE_ME"

ref_b1_0_meta_CLEAN":"REMOVE_ME"

ref_b1_0_meta_DONE":"REMOVE_ME"

ref_b1_0_meta_GOODBYE":"REMOVE_ME"

ref_b1_0_meta_THE_END":"REMOVE_ME"

ref_b1_0_meta_FINALIZED":"REMOVE_ME"

ref_b1_0_meta_PURGE":"REMOVE_ME"

ref_b1_0_meta_BLANK":"REMOVE_ME"

ref_b1_0_meta_NULLIFY":"REMOVE_ME"

ref_b1_0_meta_DELETE":"REMOVE_ME"

ref_b1_0_meta_CLEANUP_COMPLETE":"REMOVE_ME"

ref_b1_0_meta_DISREGARD":"REMOVE_ME"

ref_b1_0_meta_OBSOLETE":"REMOVE_ME"

ref_b1_0_meta_END":"REMOVE_ME"

ref_b1_0_meta_FINAL":"REMOVE_ME"

ref_b1_0_meta_STRIP2":"REMOVE_ME"

ref_b1_0_meta_STRIP3":"REMOVE_ME"

ref_b1_0_meta_STRIP4":"REMOVE_ME"

ref_b1_0_meta_STRIP5":"REMOVE_ME"

ref_b1_0_meta_STRIP6":"REMOVE_ME"

ref_b1_0_meta_STRIP7":"REMOVE_ME"

ref_b1_0_meta_STRIP8":"REMOVE_ME"

ref_b1_0_meta_STRIP9":"REMOVE_ME"

ref_b1_0_meta_STRIP10":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_2":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_3":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_4":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_5":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_6":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_7":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_8":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_9":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_10":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_11":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_12":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_13":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_14":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_15":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_16":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_17":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_18":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_19":"REMOVE_ME"

ref_b1_0_meta_FINAL_EXTRA_20":"REMOVE_ME"

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required with documentation

Provider must obtain prior authorization demonstrating: diagnosis of osteoporosis in a post‑menopausal woman; a trial of bisphosphonate treatment that was ineffective, contraindicated, or not tolerated; fulfillment of either very high‑risk criteria (BMD T‑score ≤ -3.0 or FRAX osteoporotic fracture score ≥ 30% or FRAX hip fracture score ≥ 4.5%) or a history of osteoporotic fracture. Authorization request must document that the member is receiving calcium 1000 mg and at least 400 IU of vitamin D daily while on romosozumab and that romosozumab will not be used concomitantly with abaloparatide, teriparatide, or denosumab.

codes: ["J3111"]

Billing Rule

Quantity limits

If approved, romosozumab is authorized for up to 2 injections per month (2.34 mL (210 mg) per 30 days) with a maximum of 12 fills per lifetime. Authorization period if approved: 1 year (subject to benefit changes).

J3111
Limit: up to 2 injections per month
Maximum: 12 fills per lifetime
Authorization period: 1 year

Denial Risk

Therapy not approved without required criteria

Therapy may be denied if the claim lacks required documentation or shows concomitant use of prohibited agents. Missing or insufficient documentation elements that risk denial include:

Prior bisphosphonate trial status (ineffective, contraindicated, or not tolerated)
Risk criteria: BMD T‑score ≤ -3.0 or FRAX osteoporotic fracture score ≥ 30% or FRAX hip fracture score ≥ 4.5%, or history of osteoporotic fracture
Documentation of calcium 1000 mg and at least 400 IU vitamin D daily while on therapy
Evidence romosozumab is not being used concomitantly with abaloparatide, teriparatide, or denosumab

OpenPayer

Coverage Summary

Initial Therapy Criteria

Continuation / Quantity Limits

Prior Authorization & Documentation Requirements

Applicable Codes

Clinical Background

Evidence & Rationale

Revision History